BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I'VISION

    MDR report key: 1040051 · Received May 7, 2008

    Report

    Report Number
    2182207-2008-02421
    Event Type
    Injury
    Date Received
    May 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN OVERDOSE DUE TO A CALCULATION OR CONCENTRATION ERROR. THE PT COULD NOT MOVE AT THE TIME. THE PT RECOVERED AND WAS REPORTEDLY "DOING FINE". THE CONCENTRATION AND DAILY DOSE OF LIORESAL BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I'VISION LKK RICE CREEK MANUFACTURING 8840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LOT# NGP311803H| IMPLANTABLE INFUSION PUMP MODEL 863720| EXPLANTED| CATHETER MODEL 8709SC